Acadia Pharmaceuticals Reports First Quarter 2021 Financial Results

Rhea-AI Summary

Acadia Pharmaceuticals reported Q1 2021 financial results with net sales of NUPLAZID (pimavanserin) at $106.6 million, an 18% increase year-over-year. The company faces challenges, having received a Complete Response Letter from the FDA regarding its sNDA for dementia-related psychosis. R&D expenses decreased to $57 million, while SG&A expenses rose to $111.7 million. Acadia reiterated NUPLAZID net sales guidance of $510-$550 million but revised R&D and SG&A guidance downwards, reflecting strategic adjustments. The company had a net loss of $66.4 million for the quarter.

Positive

• NUPLAZID net sales grew 18% year-over-year, totaling $106.6 million.
• The company maintains its net sales guidance of $510-$550 million for 2021.

Negative

• Received a Complete Response Letter from the FDA regarding the sNDA for NUPLAZID.
• Decreased R&D guidance from $300-$320 million to $280-$300 million.
• Increased SG&A expenses to $111.7 million, up from $102 million.

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its financial results for the first quarter ended March 31, 2021.

“NUPLAZID delivered strong year-over-year performance in the first quarter of 2021. Looking ahead, we see positive signs in the Parkinson’s disease psychosis market supporting revenue growth for the remainder of the year as we anticipate continued improvements in the conditions related to the pandemic,” said Steve Davis, Chief Executive Officer. “Furthermore, we look forward to a Type A meeting with the FDA to discuss an approval path for pimavanserin in dementia-related psychosis and we continue to advance our two Phase 3 programs for Rett syndrome and the negative symptoms of schizophrenia, as well as our Phase 2 pain program and earlier pipeline opportunities.”

Company Updates

• The Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for NUPLAZID^® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The Company plans to conduct a Type A meeting with the FDA to discuss the CRL and potential next steps to support an approval.

• Top-line results from the Phase 3 LAVENDER study evaluating trofinetide for the treatment of Rett syndrome are expected in the fourth quarter of 2021.

• A Phase 2 study was initiated evaluating ACP-044, a novel, first-in-class, orally administered, non-opioid analgesic for the treatment of postoperative pain following bunionectomy surgery in March 2021.

• A Phase 2 study evaluating ACP-044 for the treatment of pain associated with osteoarthritis is expected to commence in the second quarter of 2021.

Financial Results

Revenue

Net sales of NUPLAZID (pimavanserin) were $106.6 million for the three months ended March 31, 2021, an increase of 18% as compared to $90.1 million reported for the three months ended March 31, 2020.

Research and Development

Research and development expenses for the three months ended March 31, 2021 were $57.0 million, compared to $72.6 million for the same period of 2020. This decrease was primarily due to the $10.0 million upfront payment to Vanderbilt University for the M1 PAM program incurred during the three months ended March 31, 2020 and decreased development costs associated with pimavanserin for major depressive disorder.

Selling, General and Administrative

Selling, general and administrative expenses for the three months ended March 31, 2021 were $111.7 million, compared to $102.0 million for the same period of 2020. This increase was primarily due to increased costs associated with preparations for the potential DRP launch, partially offset by a decrease in stock-based compensation expense.

Net Loss

For the three months ended March 31, 2021, Acadia reported a net loss of $66.4 million, or $0.42 per common share, compared to a net loss of $88.0 million, or $0.57 per common share, for the same period in 2020. The net losses for the three months ended March 31, 2021 and 2020 included $13.2 million and $22.3 million, respectively, of non-cash stock-based compensation expense.

Cash and Investments

At March 31, 2021, Acadia’s cash, cash equivalents, and investment securities totaled $577.8 million, compared to $632.0 million at December 31, 2020.

2021 Financial Guidance

• Acadia is reiterating its NUPLAZID net sales guidance of $510 to $550 million.
• GAAP R&D guidance is decreased to $280 to $300 million from the previous range of $300 to $320 million. Current R&D guidance includes approximately $25 million of stock-based compensation expense.
• GAAP SG&A guidance is decreased to $385 to $415 million from the previous range of $560 to $590 million. Previous guidance included additional investments associated with the potential DRP launch in 2021 and updated guidance reflects a reduction in these expenses. Current SG&A guidance includes approximately $50 million of stock-based compensation expense.

Conference Call and Webcast Information

Acadia management will review its first quarter financial results and operations via conference call and webcast today at 5:00 p.m. Eastern Time. The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 4568937). A telephone replay of the conference call may be accessed through May 19, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4568937). The conference call also will be webcast live on Acadia’s website, www.acadia-pharm.com, under the investors section and will be archived there until June 2, 2021.

About NUPLAZID^® (pimavanserin)

NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated

FAQ

What were Acadia Pharmaceuticals' Q1 2021 earnings results?

For Q1 2021, Acadia reported NUPLAZID sales of $106.6 million and a net loss of $66.4 million.

What is Acadia Pharmaceuticals' stock symbol?

The stock symbol for Acadia Pharmaceuticals is ACAD.

What challenges did Acadia Pharmaceuticals face in Q1 2021?

Acadia received a Complete Response Letter from the FDA regarding its sNDA for NUPLAZID for dementia-related psychosis.

What is the 2021 financial guidance for Acadia Pharmaceuticals?

Acadia reiterated its NUPLAZID net sales guidance of $510-$550 million but reduced R&D and SG&A expense guidance.